Device Classification Name |
Condom
|
510(k) Number |
K082529 |
Device Name |
ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM |
Applicant |
ALATECH HEALTHCARE, LLC. |
1600 STATE DOCKS RD. |
EUFAULA,
AL
36027
|
|
Applicant Contact |
NEIL ANDERSON |
Correspondent |
ALATECH HEALTHCARE, LLC. |
1600 STATE DOCKS RD. |
EUFAULA,
AL
36027
|
|
Correspondent Contact |
NEIL ANDERSON |
Regulation Number | 884.5300 |
Classification Product Code |
|
Date Received | 09/02/2008 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|